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The agency issued a draft guidance on developing new medication-assisted treatments for opioid-use disorder.
On Aug. 6, 2018, FDA issued a new draft guidance providing recommendations for the development of new medication-assisted treatment (MAT) drugs for the treatment of opioid use disorder (OUD). The guidance, “Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Medication-Assisted Treatment”, outlines new ways for drug developers to consider measuring and establishing the effectiveness and benefits of new or existing MAT products.
The new draft guidance identifies several additional potential clinical endpoints and other outcome measures that drug developers may consider. For example, FDA encourages drug sponsors to consider a variety of ways to evaluate the effect and clinical benefit of MAT. These include the impact of a new drug on adverse outcomes like mortality (overall mortality or overdose mortality), emergency medical interventions and hepatitis C seroconversion (the period during which antibodies develop and become detectable). Efficacy may also be measured by studying the proportion of patients that transition from meeting criteria for being diagnosed with moderate to severe OUD at baseline-based on both drug use and its impact on patient wellbeing-to being considered in remission at the end of the study. Improvements in the ability to resume work, school, or other productive activity may also demonstrate clinical benefit.
“The evidence is clear: MAT works, and it is a key piece of defeating the drug crisis facing our country,” said US Health & Human Services Secretary Alex Azar, in an agency press release. “The FDA’s new guidances have the potential to bring new medications to market that are more closely tailored to patient needs and help give Americans facing addiction a better chance at recovery.”
This recent guidance builds on another draft guidance issued by the agency in April 2018 that outlines FDA’s current thinking about drug development and trial design issues relevant to the study of depot buprenorphine products (i.e., modified-release products for injection or implantation). FDA also recently published a paper with the National Institute on Drug Abuse that describes efforts to overcome some of the barriers to new drug development and the issues with determining effectiveness. In an effort to incorporate patient experience into the drug development and review paradigm, the agency also held a meeting in April 2018 to hear directly from those with OUD on a range of topics, including the effects on their health and well-being that have the greatest impact on daily life, their experience using prescription medical treatments and other treatments or therapies for OUD, and challenges or barriers to accessing or using medical treatments for OUD.
“As we seek to help those with an opioid use disorder transition to lives of sobriety, we recognize there’s great interest in new treatment options that result in meaningful outcomes for patients,” said FDA Commissioner Scott Gottlieb, MD, in the release. “For example, we must consider new ways to gauge success beyond simply whether a patient in recovery has stopped using opioids, such as reducing relapse overdoses and infectious disease transmission. Treatments that can impact these aspects of addiction can be important parts of a comprehensive approach to the treatment of opioid use disorder.”